CHMP建议批准GSK黑色素瘤药物Mekinist

关键词:葛兰素史克,黑色素瘤,Mekinist,trametinib,BRAF V600突变

2014年4月26日讯 /生物谷BIOON/ --葛兰素史克(GSK)4月25日宣布,黑色素瘤药物Mekinist(trametinib)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议批准Mekinist作为一种单药疗法,用于携带BRAF V600突变(V600E或V600K)的不可切除性或转移性黑色素瘤成人患者的治疗。Mekinist不适用于既往接受过BRAF抑制剂疗法的患者的治疗。在接受Mekinist治疗前,患者必须经过一款伴侣诊断试剂盒(THxID-BRAF)检测证实存在BRAF V600突变。

CHMP的积极意见,是基于一项随机、开放标签III期研究和一项非随机II期研究的数据。III期研究在322例携带BRAF V600突变(V600E和V600K)的黑色素瘤患者中开展,将trametinib单药疗法与化疗进行了对比。II期研究在在97例携带BRAF V600突变的黑色素瘤患者中开展,研究中将患者分为2组:BRAF抑制剂经治组和BRAF抑制剂初治组。

CHMP的积极意见是药物在欧盟上市前的最后一个监管步骤。欧盟委员会(EC)预计将于2014年第二季度做出最终审查决定。

转移性黑色素瘤中,约有一半携带BRAF突变,该异常突变能促使黑色素瘤生长和扩散。其中,BRAF V600E突变和BRAF V600K突变分别约占转移性黑色素瘤所有BRAF V600突变的85%和10%。

关于Mekinist(trametinib):

Mekinist是首个MEK抑制剂,靶向于MAPK信号通路,该通路调节细胞的正常生长和死亡,包括皮肤细胞,在转移性黑色素瘤中发挥着关键作用。

Mekinist已获FDA和澳大利亚批准,作为单药疗法或与黑色素瘤药物Tafinlar(dabrafenib)联合用药。此外,加拿大也已批准Mekinist作为一种单药疗法。

Tafinlar是GSK开发的另一种黑色素瘤药物,该药是一种BRAF抑制剂,适用于携带BRAF V600E突变的手术不可切除性或转移性黑色素瘤成人患者的治疗,该药不适用于野生型BRAF黑色素瘤患者的治疗。(生物谷Bioon.com)

英文原文:GSK receives positive CHMP opinion for Mekinist™ (trametinib) in metastatic melanoma with a BRAF V600 mutation

Issued: Friday 25 April 2014, London UK

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Trametinib as a single agent has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of BRAF V600 mutation using a validated test.

Dr Rafael Amado, Head of Oncology R&D at GSK said: “This CHMP opinion brings us a step closer to making another personalised medicine available for patients with BRAF-mutant metastatic melanoma in Europe.”

The CHMP recommendation for trametinib monotherapy is based on a randomised open label phase III study comparing trametinib to chemotherapy in 322 patients with BRAF mutant melanoma (V600E and V600K) and a non-randomised phase II study in 97 patients with BRAF mutant melanoma split in two cohorts: previously treated or not treated with a BRAF inhibitor.

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the second quarter of 2014.

About Mekinist

Mekinist is a MEK inhibitor that targets the MAPK pathway, which regulates the normal growth and death of cells, including skin cells and plays a role in metastatic melanoma development.

Mekinist is approved as a single agent and in combination with Tafinlar (dabrafenib) in the US and Australia. Mekinist is also approved as monotherapy in Canada. Detailed prescribing information, which may differ between the countries, can be accessed:

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